510(k) K173577
K173577 is an FDA 510(k) premarket notification submitted by International Medical Industries, Inc. for the device "Guarded Luer Connector". The FDA issued a decision of Substantially Equivalent on June 7, 2018. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. International Medical Industries, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 2018
- Date Received
- November 20, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, I.V. Fluid Transfer
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type